> Emergency Medicine > Research > Rescu > Current Studies > ROC ALPs

ROC ALPs

Amiodarone (PM101), Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia (ALPS: Amiodarone, Lidocaine or Placebo Study)

The goal of ALPS is to determine if survival to hospital discharge is improved with early (and if necessary) repeated therapeutic administration of a new Captisol-Enabled formulation of IV amiodarone (PM101) compared to no antiarrhythmic drug (placebo) or lidocaine. It will compare the benefit of what is believed (but as yet unproven) to be the most effective antiarrhythmic drug (amiodarone) against the traditional standard drug (lidocaine) and against neither (placebo) in shock-resistant cardiac arrest. As such, it will potentially answer 2 critical questions: (1) are antiarrhythmic drugs effective for the treatment of VF cardiac arrest? (2) is amiodarone preferable to lidocaine for such treatment? Answering these questions will determine the proven role (if any) of antiarrhythmic drugs for future generations of patients with out-of-hospital cardiac arrest.

Antiarrhythmic medications (amiodarone, lidocaine) are frequently used as part of advanced care to treat ventricular arrhythmias that persist or recur during a cardiac arrest. Although much is known about the pharmacological effects of these drugs, there is a considerable gap in knowledge between our understanding of their mechanisms of action and whether their use actually improves survival after cardiac arrest. No pharmacologic agent has ever been demonstrated to improve survival to hospital discharge after cardiac arrest. It is not known whether these drugs may cause more harm than good.

The study will be done at 10 locations across the U.S. and Canada. Almost 70 EMS organizations, involving more than 10,000 EMS providers who serve a combined population of nearly 15 million people from diverse urban, suburban and rural regions will participate in the ROC Continuous Cardiac Compressions study.

Approximately 3,000 patients will be enrolled at all of the ROC regions in Canada and the United States and it is expected to last approximately 3 years.

ALPS Trial Update

This study is a double-blinded randomized control trial that will be looking at the efficacy of antiarrhythmics (amiodarone and lidocaine) in their treatment of out of hospital cardiac arrest (OHCA) patients who experience a sustained ventricular dysrhythmia (ventricular fibrillation or pulseless ventricular tachycardia). 

A double blinded randomized control trial means that the person administering the medication and the person receiving the medication does not know which one they are receiving. This will ensure that most confounding factors will be eliminated from the study and that the science will be strong enough to show significant results that one medication is better than the other or not.

The ALPS trial was delayed by a number of unforeseeable issues but having crossed all those hurdles and bumpy roads, we launched the trial last year at 3 of our Emergency Medical Services, Halton, Peel, Toronto and this year by the Durham EMS on Feb 9th and the latest service to join in was the Regional Municipality of York EMS on April 15th, 2013.

Here is a sample of the enrollment numbers by regions and the launch dates of each service across the RescuNet since the start of the trial. 

Service

Launch Date

# of patient enrolled
(as of Aug 8, 2014)

Durham EMS

Feb 9, 2013

55

Halton EMS

Oct 16, 2012

72

Peel EMS

Oct 23, 2012

182

Toronto EMS

Nov 1, 2012

231

Regional Municipality of York EMS

Apr 15, 2013

62

Total

602


All of the participating services are doing an excellent job enrolling patients and ensuring that the trial runs smoothly.  This is happening due to the cooperation and support from the paramedics towards research, service educators dedication to train the medics on the study, the operation staff at each of the services responsibly handling the tracking and distribution of the ALPs kits to the stations/trucks/bags, the supervisors replacing the same with the kits, ensuring that the kits are always available for in the trucks/bags for medics to use when there is a case. 

At times you may have the question knocking on the doors  of your brain - why do this study and  it has come to our attention that there are still some questions surrounding the ALPs study. So, we have few friendly reminders from your friends at Rescu posted below “Top Reasons for enrolling into the ALPs study”!Additionally, the ALPs reminder posters have been distributed to all the participating services and we believe that these will be helpful and remind the medics about who should get ALPs drug and when to enroll the patients into the ALPs trial.

Thank you for all of your dedication and support to this very important trial.

The ClinicalTrials.gov registration number is NCT01401647.

Click here for Helpful hints on attachment of adaptor with ALPS syringes

Click here for CME Training Slides

Click here for ALPS training slides from ROC

Click here for more information on ROC ALPs (Interview with Dr. Laurie Morrison)

Click here for Top Reasons for enrolling into the ALPs study

UofT logo Emergency Medicine logo Department of Medicine